Expanded Access Program for Taletrectinib in Patients with Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

Sponsor: Nuvation Bio Inc.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06841874

Provider View

This program offers access to the drug taletrectinib for patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who cannot use approved treatments or join ongoing clinical trials.

Patient Parameters

Program Overview

This program provides the opportunity for patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) to receive taletrectinib. It is intended for those who cannot use approved treatments like crizotinib, entrectinib, or repotrectinib, or participate in ongoing clinical trials, and who may benefit from this treatment according to their doctor.

Description

The Expanded Access Program allows patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) to access taletrectinib. This is for patients who are not suitable for approved treatments, such as crizotinib, entrectinib, or repotrectinib, or who cannot join ongoing clinical trials. The program is designed for those who, in their doctor's opinion, might benefit from taletrectinib treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC).
  • Cancer must show evidence of ROS1 gene fusion.
  • Have good bone marrow and organ function.
  • Cannot join the ongoing Nuvation Bio clinical trial AB-106-G208, unless there are specific reasons preventing participation.
  • Have tried and not benefited from approved therapies or are not suitable for them.

Exclusion Criteria

  • Must wait for a certain period after previous cancer treatments before starting this program.
  • Cannot have acute medical conditions needing immediate treatment, like a new blood clot in the lungs or spinal cord issues needing urgent care.
  • Cannot have unresolved lung conditions like interstitial fibrosis or drug-induced lung inflammation.
  • Cannot have active, untreated hepatitis B or C, unless it is stable.
  • Cannot have certain heart rhythm problems or a family history of long QT syndrome.

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